Proteomic Analysis of Serum Samples After Cardiac Arrest: a TTM-trial Substudy (NCT07017374) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Proteomic Analysis of Serum Samples After Cardiac Arrest: a TTM-trial Substudy
Sweden682 participantsStarted 2025-05-22
Plain-language summary
Cardiac arrest remains a large contributor to morbidity and mortality. Animal studies suggest an improvement in mortality and neurological function with hypothermia after cardiac arrest, a finding that could not be verified in large clinical trials such as Target Temperature Management after Out-of-hospital Cardiac arrest (TTM) trial. Multimodal neuroprognostication is an important tool for differentiating patients that will recover after cardiac arrest, and currently only one biomarker is in clinical use. The purpose of this study is to explore proteomics profiles in TTM trial patients in order to search for potential novel biomarkers, therapeutic targets, and to explore phenotypes of post-cardiac arrest syndrome.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria as defined in the TTM trial (NCT01020916):
* Age ≥ 18 years old
* Out-of-hospital cardiac arrest (OHCA) of presumed cardiac cause
* Return of spontaneous circulation (ROSC)
* Unconsciousness (Glasgow Coma Score \< 8) (patients not able to obey verbal commands) after sustained ROSC
Exclusion Criteria as defined in the TTM trial (NCT01020916):
* In-hospital cardiac arrest
* OHCA of presumed non-cardiac cause, e.g. after trauma or dissection/rupture of major artery OR Cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging).
* Known bleeding diathesis (medically induced coagulopathy (e.g warfarin, clopidogrel) does not exclude the patient).
* Suspected or confirmed acute intracranial bleeding
* Suspected or confirmed acute stroke
* Unwitnessed asystole
* Known limitations in therapy and Do Not Resuscitate-order
* Known disease making 180 days survival unlikely
* Known pre-arrest CPC 3 or 4
* Temperature \< 30°C on admission
* \> 4 hours (240 minutes) from ROSC to screening
* Systolic blood pressure \< 80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump. If the systolic blood pressure (SBP) is recovering during the inclusion window (220 minutes) the patient can be included.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying proteins in the blood of cardiac arrest survivors — can you explain what 'proteomic analysis' means in plain terms, and what the researchers hope to learn from comparing protein levels in people who had cardiac arrests?
2Since this study is listed as 'active, not recruiting,' enrollment is already closed — are there any similar observational studies or follow-up research currently open that I or a family member affected by cardiac arrest might be eligible to participate in?
3This appears to be a substudy of a temperature management (TTM) trial — can you help me understand how the findings from studying these blood proteins might eventually influence how cardiac arrest patients are treated, even if the research benefits are long-term rather than immediate?
4Because this is an observational proteomics study rather than a treatment trial, does participating in something like this involve any direct risks or benefits to the patient, or is it purely about contributing blood samples for research purposes?
5Given that this trial focuses on cardiac arrest survivors, are there any current treatment trials or evidence-based standard-of-care approaches you'd recommend we discuss for someone in our situation, since this particular study isn't enrolling new participants?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differential protein abundance
Timeframe: Differential protein abundance is evaluated 24, 48, and/or 72 hours after return of spontaneous circulation after cardiac arrest. Clinical outcomes are evaluated 180 days after cardiac arrest.